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Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners (HIH)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Psychological intervention
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, Partners, Couples, Attachment, Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women newly diagnosed with a primary breast cancer (in the last 4 weeks)
  • Women cohabiting with a male partner in a romantic relationship
  • Patient and partner speaks and reads danish

Exclusion Criteria:

  • Patients having a previous cancer diagnosis
  • Neoadjuvant therapy for breast cancer
  • Previous hospital admission with diagnosed psychotic episodes

Sites / Locations

  • Herlev University Hospital
  • Odense University Hospital
  • Ringsted Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Psychological Intervention

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Change in Impact of Event Scale (IES)
IES assesses traumatic reactions to the breast cancer diagnosis. Assessed by both patients and partners
Change in The Hospital Anxiety and Depression Scale (HADS)
Assesses feelings of anxiety and depressive symptoms. Assessed by both patients and partners.
Change in The Profile of Mood States - Short Form (POMS-SF)
Assesses mood changes. Assessed by both patients and partners

Secondary Outcome Measures

Change in Dyadic Adjustment Scale - Revised (DAS-R)
Assesses relationship functioning and marital satisfaction. Assesed by both patients and partners
Change in Relationship Questionnaire (RQ)
RQ provides a profile of an individual's attachment feelings and behaviour. Assessed by both patients and partners
Change in Functional Assessment of Cancer Therapy - Breast (FACT-B)
Assesses health-related quality of life with additional questions for women dignosed with breast cancer.
Change in Functional Assessment of Cancer Therapy - general population (FACT-GP)
Assesses health-related quality of life. Assessed by partners
Change in Functional Assessment of Chronic Illness Therapy-Fatigue
Assesses individual fellings of fatigue. Assessed by the patients
Change in Post Traumatic Growth Inventory
Assesses positive changes in individuals experiencing traumatic life events. Assessed by both patients and partners
Change in EuroQol-5 Dimensions (EQ-5D)
Assesses health-related quality of life. Assessed by both patients and partners

Full Information

First Posted
May 23, 2011
Last Updated
February 25, 2015
Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital, Ringsted Hospital, University of Copenhagen, Region of Southern Denmark, Danish Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT01368380
Brief Title
Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners
Acronym
HIH
Official Title
Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital, Ringsted Hospital, University of Copenhagen, Region of Southern Denmark, Danish Cancer Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care
Detailed Description
The intervention intends to improving the patient and partners well-being, quality of life and their relationship adjustment. The couples in the intervention group participates i six to eight couple sessions. The sessions is conducted by an experienced psychologist and takes place one to five months after the patients cancer diagnosis. The control group receives usual care. The framework of the intervention is attachment theory and the psychologists support and advise the couples in talking candidly about their feelings regarding their new life situation with cancer. The psychologist focus on the couples ability to feel comfortable and safe in each others presence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Partners, Couples, Attachment, Intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychological Intervention
Arm Type
Experimental
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Psychological intervention
Intervention Description
Couples in the intervention group attends six to eight couple-sessions performed by a psychologist.
Primary Outcome Measure Information:
Title
Change in Impact of Event Scale (IES)
Description
IES assesses traumatic reactions to the breast cancer diagnosis. Assessed by both patients and partners
Time Frame
Baseline, 2 weeks post-intervention, 10 months follow-up
Title
Change in The Hospital Anxiety and Depression Scale (HADS)
Description
Assesses feelings of anxiety and depressive symptoms. Assessed by both patients and partners.
Time Frame
Baseline, 2 weeks post-intervention, 10 months follow-up
Title
Change in The Profile of Mood States - Short Form (POMS-SF)
Description
Assesses mood changes. Assessed by both patients and partners
Time Frame
Baseline, 2 weeks post-intervention, 10 months follow-up
Secondary Outcome Measure Information:
Title
Change in Dyadic Adjustment Scale - Revised (DAS-R)
Description
Assesses relationship functioning and marital satisfaction. Assesed by both patients and partners
Time Frame
Baseline, 2 weeks post-intervention, 10 months follow-up
Title
Change in Relationship Questionnaire (RQ)
Description
RQ provides a profile of an individual's attachment feelings and behaviour. Assessed by both patients and partners
Time Frame
Baseline, 2 weeks post-intervention, 10 months follow-up
Title
Change in Functional Assessment of Cancer Therapy - Breast (FACT-B)
Description
Assesses health-related quality of life with additional questions for women dignosed with breast cancer.
Time Frame
Baseline, 2 weeks post-intervention and 10 months follow-up
Title
Change in Functional Assessment of Cancer Therapy - general population (FACT-GP)
Description
Assesses health-related quality of life. Assessed by partners
Time Frame
Baseline, 2 weeks post-intervention and 10 months follow-up
Title
Change in Functional Assessment of Chronic Illness Therapy-Fatigue
Description
Assesses individual fellings of fatigue. Assessed by the patients
Time Frame
Baseline, 2 weeks post-intervention and 10 months follow-up
Title
Change in Post Traumatic Growth Inventory
Description
Assesses positive changes in individuals experiencing traumatic life events. Assessed by both patients and partners
Time Frame
2-weeks post-intervention and 10 months follow-up
Title
Change in EuroQol-5 Dimensions (EQ-5D)
Description
Assesses health-related quality of life. Assessed by both patients and partners
Time Frame
Baseline, 2 weeks post-intervention and 10 months follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women newly diagnosed with a primary breast cancer (in the last 4 weeks) Women cohabiting with a male partner in a romantic relationship Patient and partner speaks and reads danish Exclusion Criteria: Patients having a previous cancer diagnosis Neoadjuvant therapy for breast cancer Previous hospital admission with diagnosed psychotic episodes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorte G Hansen, PhD
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mariët Hagedoorn, Professor
Organizational Affiliation
University of Groningen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christoffer Johansen, Professor
Organizational Affiliation
Danish Cancer Society
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Henrik Flyger, MD, Ph. D
Organizational Affiliation
University of Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
Herlev University Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Ringsted Hospital
City
Ringsted
ZIP/Postal Code
4100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25815190
Citation
Nicolaisen A, Hansen DG, Hagedoorn M, Flyger HE, Rottmann N, Nielsen P, Soe K, Pedersen AE, Johansen C. Attachment-oriented psychological intervention for couples facing breast cancer: protocol of a randomised controlled trial. BMC Psychol. 2014 Jul 14;2(1):19. doi: 10.1186/2050-7283-2-19. eCollection 2014.
Results Reference
derived

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Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners

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